To Evaluate the Safety and Efficacy of Trexima in the Acute Treatment of Migraine Headaches
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|ClinicalTrials.gov Identifier: NCT00433732|
Recruitment Status : Completed
First Posted : February 12, 2007
Last Update Posted : February 12, 2007
|Condition or disease||Intervention/treatment||Phase|
|Migraine Headaches||Drug: sumatriptan Drug: naproxen sodium||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1400 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Double-Blind, Multicenter, Randomized, Placebo-Controlled Single Dose Study to Evaluate the Safety and Efficacy Opf Trexima in the Acute Treatment of Migraine Headaches|
|Study Start Date :||August 2004|
|Estimated Study Completion Date :||April 2005|
- Trexima will be evaluated for efficacy as an acute treatment for migraine based on its superiority over placebo at 2 hours for: a) pain relief (no or mild pain), b) incidence of photophobia, c) incidence of phonophobia and d) incidence of nausea.
- a) sustained pain relief over 24 hours, b) sustained photophobia-free over 24 hours, c) sustained phonophobia-free over 24 hours, and d) sustained nausea-free over 24 hours.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00433732
|United States, Arkansas|
|Little Rock Family Practice Clinic|
|Little Rock, Arkansas, United States, 72205|
|United States, North Carolina|
|Chapel Hill, North Carolina, United States, 27517|
|Study Director:||David Taylor||POZEN|